The amended standard NF EN ISO 14971 has been published in its December 2021 version.

Added Annexes ZA and ZB highlight the relationship between the standard and the relevant general safety and performance requirements of Regulations (EU) 2017/745 and 2017/746.

The standard does not include annexes establishing its link with the requirements of the 3 directives: 90/385/EEC, 93/42/EEC and 98/79/EC.


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